FDA applicant

Integra Lifesciences Corporation (Owner of Tei Biosciences)

Boston, MA1 decision2017–20172 recalls

FDA records 1 decision for Integra Lifesciences Corporation (Owner of Tei Biosciences) (Boston, MA) in 2017: 1 510(k) clearance. All are in product code OXH (Mesh, Surgical, Collagen, Plastic And…). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Integra Lifesciences Corporation (Owner of Tei Biosciences)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2023

2017high 2 (2023) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Integra Lifesciences Corporation (Owner of Tei Biosciences) by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Integra”

FDA records each applicant name separately; these may or may not be the same firm.

Integra LifeSciences Corporation 101 Integra Neurocare, LLC 12 Integra Radionics, Inc. 10 Integra Neurosciences 9 Integra Lifesciences Production Corporation 9 Integra Neurosciences Implants S.A. 6 Integra Life Sciences 3 Integra Medical 2 Integra Lifescience Corportation 2 Integra Microfrance 1 Integra Biotechnical, LLC 1 Integra Burlington Ma, Inc. 1

Integra Lifesciences Corporation (Owner of Tei Biosciences)

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Integra”